The Dry Laser Imager, DRYPRO Model 832 is intended to be used to receive image data from diagnostic equipment such as CT, MRI, DSA and other medical devices and print them on medical dry-film. The output image is not a high resolution and DRYPRO Model 832 is not intended for use with FFDM systems.

Device Description

The Dry Laser Imager, DRYPRO Model 832 is a Laser Imager to receive image data from diagnostic equipment such as CT, MRI, DSA and other medical devices and print them on medical dry-film. The device consists of film supplying unit, film transferring unit, exposing unit, heat-developing unit, operating unit, power supplying unit and main control unit. This product employs semiconductor laser scanning, but it complies with the Federal Performance Standard 21 CFR Part 1040.10. This device has no patient contacting materials and is intended to be used by trained personnel only. The output of the device is evaluated by additionally trained personnel capable of sufficient review to afford identification and intervention in case of malfunction.

AI/ML Overview

This document describes the Konica Minolta Medical & Graphic, Inc. Dry Laser Imager, DRYPRO Model 832, a medical image hardcopy device, seeking 510(k) clearance. The device is intended to receive image data from diagnostic equipment (CT, MRI, DSA) and print it on medical dry-film. It explicitly states that the output image is not high resolution and is not intended for use with FFDM (Full Field Digital Mammography) systems.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a typical quantitative pass/fail format for clinical performance. Instead, it presents a comparison table between the new device (DRYPRO Model 832) and its predicate device (DRYPRO Model 771) to demonstrate substantial equivalence based on technical specifications and intended use. The implicit acceptance criterion is that the new device's performance characteristics are comparable to or improved over the predicate device, or any changes do not raise new questions of safety or effectiveness.

Item	Predicate Device (DRYPRO Model 771) Reported Performance	New Device (DRYPRO Model 832) Reported Performance
Laser Source	Laser Diode [LD] (810nm)	Laser Diode [LD] (785nm)
Laser Power	100mW (Maximum Output)	240mW (Maximum Output)
Laser Modulator	Direct driving modulator	Direct driving modulator
Film Type	Konica Medical Imaging Film (SD-P & SD-Pc)	Konica Medical Imaging Film (SD-P & SD-Pc)
Film Sizes	14"x 17", 14"x 14", 11"x 14"	14"x 17", 14"x 14", 11"x 14", 10"x 12", 8"x 10"
Film Supply	1 unit	1 unit or 2 units (125 or 50 film on each) for installation of Optional Supply
Interface	10/100base-TX, 4 network ports maximum	10/100/1000base-TX, 4 network ports maximum
Protocol	DICOM version 3.0, Print service class	DICOM version 3.0, Print service class
Image Data Storage	one Hard Disk Drive	outside PC
Image Formatting	1,2,4,6,9,12,15,16,20,24,25,30,35,36,42, and 48 frame formats, and mixed formats available.	1,2,4,6,9,12,15,16,20,24,25,30,35,36,42, and 48 frame formats, and mixed formats available.
Pixel Size	78.6 micro-meters minimum	78.6 micro-meters minimum
Density Resolution	14bits / pixel	14bits / pixel
Cycle Time	30 sec.	40 sec.
Test Pattern	Pre-programmed SMPTE pattern	Pre-programmed SMPTE pattern
Smoothing	Choice of Pixel replication, Bi-linear. Spline functions via network	Choice of Pixel replication, Bi-linear. Spline functions via network
Image Rotation	Choice of 0 (normal), 90 degrees via network	Choice of 0 (normal), 90 degrees via network
Exposure Setting	8 types / port via network	8 types / port via network
Image Borders	Choice of black or clear via network	Choice of black or clear via network
Image Framing	Choice of framing or no framing via network	Choice of framing or no framing via network
Print Developing	Choice between negative and positive printing via network	Choice between negative and positive printing via network
Character Input	Data and message data printed in margins via network	Data and message data printed in margins via network
Copying	99 copies per print maximum via network	99 copies per print maximum via network
Controller Display	Backlight liquid-crystal display (20 places, 2 lines)	Backlight liquid-crystal display (20 places, 2 lines)
External Dimensions	W630mm x D600mm x H1125mm	W599mm x D585mm x H570mm
Weight	Approx. 175Kg	Approx. 95Kg
Power Consumption	1020VA maximum (destination of USA)	1200VA maximum (destination of USA)
Exhaust Heat	Approx. 950kJ / hour	Approx. 1200kJ / hour
Purpose of use	The device is intended for the use at the X-ray department of the hospital, etc. the device that will acquire data from diagnostic equipment and then print the data onto laser imaging film.	The device is intended for the use at the X-ray department of the hospital, etc. the device that will acquire data from diagnostic equipment and then print the data onto laser imaging film.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not describe a clinical performance study with a "test set" in the context of an AI/algorithm-driven device for diagnosis. This device is a hardcopy printer. The evaluation for substantial equivalence relies on comparing technical specifications and intended use with a predicate device. Therefore, there's no explicitly defined "sample size" or "data provenance" as would be relevant for an algorithm's diagnostic performance. The testing would have focused on the device's functional performance, image quality, and safety standards, but the details of such internal testing are not provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. As a medical image hardcopy device, the "ground truth" refers to the fidelity and accuracy of the printed image compared to the digital input and established image quality standards for medical prints. There are no mentions of "experts" establishing clinical ground truth for diagnostic purposes in this document, as the device does not perform diagnosis.

4. Adjudication Method for the Test Set

Not applicable for this type of device. Adjudication methods are relevant for evaluating diagnostic accuracy from algorithms or readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This device is a printer, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This is a hardware device for printing, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this hardcopy device would implicitly refer to the technical specifications of image quality (e.g., pixel size, density resolution, print fidelity) as verified against industry standards (like those in DICOM and potentially SMPTE patterns mentioned). It's about ensuring the printed output accurately represents the digital input according to established technical benchmarks, rather than a clinical ground truth for a diagnostic finding.

8. The Sample Size for the Training Set

Not applicable. This device is a laser imager, a hardware product, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Summary

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Ka61999

as required by 807.92

1. Company Identification

AUG 1 5 2006

Konica Minolta Medical & Graphic, Inc. 2970 Ishikawa-machi, Hachioji-shi, Tokyo 192-8505, Japan Tel : 81-426-60-9607 Fax: 81-426-60-9588

2. Official Correspondent

Kouji Matsushima (Mr.) Manager Advanced Technology Division R&D Center

3. Date of Submission

July 10, 2006

4. Establishment Registration No.

3003769120

5. Device Trade Name

Dry Laser Imager, DRYPRO Model 832

6. Common Name

Medical Image Hardcopy Device

7. Classification

Class II, 21 CFR 892. 2040, Medical image hardcopy device

8. Product Cord 90 LMC

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9. Predicate Device

Konica Laser Imager, DRYPRO Model 771, 510(K) No.: K032681 Comparison of the principal characteristics of the two devices which are pertinent to Specification performance is attached.

10. Description of Device

The Dry Laser Imager, DRYPRO Model 832 is a Laser Imager to receive image data from diagnostic equipment such as CT, MRI, DSA and other medical devices and print them on medical dry-film.

The device consists of film supplying unit, film transferring unit, exposing unit, heat-developing unit, operating unit, power supplying unit and main control unit.

This product employs semiconductor laser scanning, but it complies with the Federal Performance Standard 21 CFR Part 1040.10.

This device has no patient contacting materials and is intended to be used by trained personnel only.

The output of the device is evaluated by additionally trained personnel capable of sufficient review to afford identification and intervention in case of malfunction.

11. Intended Use

12. Compliance Standard

UL60601-1, UL-825-1 IEC60601-1, IEC60601-1-2, IEC60825-1, 21 CFR 1040.10, DICOM

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Item	Approved Medical Device	Medical Device Applied for Approval
Applicant,etc.

Company	Konica Minolta Medical&Graphic Inc.	Konica Minolta Medical&Graphic Inc.
Product Name	DRYPRO model 771	DRYPRO model 832
Approval No.	K032681
Configuration	The device consists of film supplying unit and filmtransferring unit and exposing unit and heat-developing unit	The device consists of film supplying unit and filmtransferring unit and exposing unit and heat-developing unit
	and operating unit and power supplying unit and main control unit	and operating unit and power supplying unit and main control unit

Principle	Select the printing format on the contoroller.	Select the printing format on the contoroller.
of Operation	Push the storing key in order to store the printing images	Push the storing key in order to store the printing images
	and push the printing key.So the film is picked up and then is transferred exposing unit.	and push the printing key.So the film is picked up and then is transferred exposing unit.
	This printing images is exposed on that film there by laser and	This printing images is exposed on that film there by laser and
	optical devices.	optical devices.
	Exposed film is transferred to heat-developing unit and	Exposed film is transferred to heat-developing unit and
	photo-finished, then ejected from	photo-finished, then ejected from

Specification
Laser Source	Laser Diode [LD] (810nm)	Laser Diode [LD] (785nm)
Laser Power	100mW (Maximum Output)	240mW (Maximum Output)
Laser Modulator	Direct driving modulater	Direct driving modulater
Film Type	Konica Medical Imaging Film (SD-P & SD-Pc)	Konica Medical Imaging Film (SD-P & SD-Pc)
Film Sizes	14"x 17",14"x 14",11"x 14"	14"x 17",14"x 14",11"x 14",10"x 12",8"x 10"
Film Supply	1 units	1 unit or
		2 units (125 or 50 film on each) for installation of Optional Supply
Interface	10/100base-TX, 4network ports maxmum	10/100/1000base-TX, 4network ports maxmum
Protocol	Digital Imaging and Communications in Medicine	Digital Imaging and Communications in Medicine
	[DICOM] version 3.0	[DICOM] version 3.0
	Print service class	Print service class
Image Data Storage	one Hard Disk Drive	outside PC

Image Formatting	1,2,4,6,9,12,15,16,20,24,25,30,35,36,42, and 48	1,2,4,6,9,12,15,16,20,24,25,30,35,36,42, and 48
	frame formats, and mixed formats available.	frame formats, and mixed formats available.
	(Possible formats limited according to the image data)	(Possible formats limited according to the image data
Pixel Size	78.6 micro-meters minimum	78.6 micro-meters minimum
Density Resolution	14bits / pixel	14bits / pixel
Cycle Time	30 sec.	40 sec.
Test Pattern	Pre-programmed SMPTE pattern	Pre-programmed SMPTE pattern
Smoothing	Choice of Pixel replication, Bi-linear.	Choice of Pixel replication, Bi-linear.
	Spline functions via network	Spline functions via network
Image Rotation	Choice of 0 (normal), 90 degrees via network	Choice of 0 (normal), 90 degrees via network
Exposure Setting	8 types / port via network	8 types / port via network
Image Borders	Choice of black or clear via network	Choice of black or clear via network
Image Framing	Choice of framing or no framing via network	Choice of framing or no framing via network
Print Developing	Choice between negative and positive printing	Choice between negative and positive printing
	via network	via network
Character Input	Data and message data printed in margins via	Data and message data printed in margins via
	network	network
Copying	99 copies per print maximum via network	99 copies per print maximum via network
Controller Display	Backlight liquid-crystal display (20places, 2lines)	Backlight liquid-crystal display (20places, 2lines)
External Dimensions	W630mm x D600mm x H1125mm	W599mm x D585mm x H570mm
Weight	Approx. 175Kg	Approx. 95Kg
Power Source	AC100~~120V 50/60Hz 、AC220~~240V 50Hz	AC100~~120V 50/60Hz , AC220~~240V 50Hz
Power Consumption	1020VA maximum(destination of USA)	1200VA maximum (destination of USA)
Work Space Environment	15~~30℃;30~~75%RH	15~~30℃;30~~75%RH
Magnetic Resistance	Up to 5 gauss	Up to 5 gauss
Exhaust Heat	Approx. 950kJ / hour	Approx. 1200kJ / hour
Optional Equipment	Warranty		12months from the time of installation	1bin Supply	12months from the time of installation
Purpose of use	The device is intended for the use at the X-raydepartment of the hospital, etc. the device that willacquire data from diagnostic equipment and thenprint the data onto laser imaging film.	The device is intended for the use at the X-raydepartment of the hospital, etc. the device that willacquire data from diagnostic equipment and thenprint the data onto laser imaging film.

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Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person embracing another person. The seal appears to be a logo or emblem representing the U.S. Department of Health and Human Services.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 1 5 2006

Mr. Koji Matsushima Manager Konica Minolta Medical & Graphic, Inc. TSG, Advanced Technology Division, R&D Center 2970 Ishikawa-machi, Hachioji-Shi, Tokyo, 192-8505 JAPAN

Re: K061999

Trade/Device Name: Dry Laser Imager, DRYPRO Model 832 Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: LMC Dated: July 10, 2006 Received: July 14, 2006

Dear Mr. Matsushima:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval}, it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, followed by the letters "FDA" in a large, bold font. Below the letters, the word "Centennial" is written in a smaller font. Three stars are arranged in a horizontal line below the word "Centennial". The entire design is enclosed within a dotted circle.

Protecting and Promoting Public Health

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Page 2 -

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K061999 510(k) Number (if known)

Device Name

Indications for Use:

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061999

Page 1 of

Regulation Number and Section

§ 892.2040 Medical image hardcopy device.

(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.